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Trial record 5 of 197 for:    Enzalutamide

A Registry Based Study Evaluating Overall Survival and Treatment Length in mCRPC Patients Treated With Enzalutamide in Sweden

This study is not yet open for participant recruitment.
Verified October 2017 by Astellas Pharma Inc ( Astellas Pharma a/s )
Sponsor:
ClinicalTrials.gov Identifier:
NCT03328364
First Posted: November 1, 2017
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma a/s )
  Purpose

The purpose of this study is to provide real world data on treatment with enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) patients.

The primary purpose is to evaluate overall survival (OS) in mCRPC patients treated with enzalutamide who have previously undergone treatment with chemotherapy (docetaxel) (post chemo patients).

This study will also evaluate treatment duration with enzalutamide in patients pre- and post-chemo.


Condition Intervention
Metastatic Castration Resistant Prostate Cancer Drug: enzalutamide Drug: docetaxel

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Registry Based Study Evaluating Overall Survival and Treatment Length in mCRPC Patients Treated With Enzalutamide in Sweden

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc ( Astellas Pharma a/s ):

Primary Outcome Measures:
  • Overall survival in metastatic castration-resistant prostate cancer (mCRPC) patients treated with enzalutamide, who have previously undergone treatment with chemotherapy (docetaxel) [ Time Frame: Up to a maximum of four years ]
    Overall survival is defined as time from initiation to death of any cause.


Secondary Outcome Measures:
  • Treatment duration of enzalutamide in pre chemo mCRPC patients [ Time Frame: Up to a maximum of four years ]
    Treatment duration is defined as time from initiation to treatment discontinuation of any cause.

  • Treatment duration of enzalutamide in post chemo mCRPC patients [ Time Frame: Up to a maximum of four years ]
    Treatment duration is defined as time from initiation to treatment discontinuation of any cause.


Estimated Enrollment: 200
Anticipated Study Start Date: December 2017
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
enzalutamide (mCRPC pre-chemo)
Patients treated with enzalutamide prior to chemotherapy
Drug: enzalutamide
oral
Other Names:
  • Xtandi
  • MDV3100
enzalutamide and chemotherapy (mCRPC post chemo)
Patients treated with enzalutamide who have previously undergone treatment with chemotherapy (docetaxel)
Drug: enzalutamide
oral
Other Names:
  • Xtandi
  • MDV3100
Drug: docetaxel
intravenous infusion

Detailed Description:
The data source in this study is a local hospital registry created from a patient follow up of prostate cancer patients.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with mCRPC initiating treatment with enzalutamide pre- and post- chemo registered in the prostate cancer registry.
Criteria

Inclusion criteria:

  • Chemo naïve mCRPC patients treated with enzalutamide and ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration).
  • mCRPC patients treated with enzalutamide and ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration) post chemo.

Exclusion Criteria

  • mCRPC patients previously exposed to Radium-223, abiraterone acetate and/or cabazitaxel for mCRPC (pre- and post chemotherapy).
  • Patients previously exposed to chemotherapy or abiraterone acetate+prednisolone in combination with GnRH analogue for hormone sensitive prostate cancer (HSPC).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328364


Contacts
Contact: Medical Affairs Europe +44(0)20 3379 8000 Astellas.registration@astellas.com

Sponsors and Collaborators
Astellas Pharma a/s
Investigators
Study Chair: Medical Scientific Advisor Astellas Pharma a/s
  More Information

Responsible Party: Astellas Pharma a/s
ClinicalTrials.gov Identifier: NCT03328364     History of Changes
Other Study ID Numbers: 9785-MA-3166
First Submitted: October 30, 2017
First Posted: November 1, 2017
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Astellas Pharma Inc ( Astellas Pharma a/s ):
enzalutamide
metastatic castration-resistant prostate cancer
Xtandi
registry based study
MDV3100
mCRPC

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action